Implication of Metabolic and Genomic Modifications in Elderly Subjects (COMPALICLAMP)

This study has been completed.
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00951392
First received: July 31, 2009
Last updated: March 8, 2010
Last verified: March 2010
  Purpose

An increase of longevity and of the number of men and women older than 60 years old is observed in most industrialized countries. Aging is a complex, multifactorial and continuous process involving physical and biological modifications such as a notably decrease in glucose tolerance and type 2 diabetes risk. Insulin sensitivity follow-up during aging is difficult mainly because of many confounding factors (environment, lifestyle).

In 2006, SUVIMAX 2 study began, based on the monitoring of volunteers who participated in former SUVIMAX study (1994-2003). This study was a randomised trial which was designed to study the link between a low antioxidant intake and risk of cancer or ischemic heart disease. The subjects recently had a health check-up including complete information about their diet, physical and neurosensory status. Based on these data, a score was established to classify subjects according to their quality of aging ("successful aging versus "problematic aging") These volunteers, who undertook a 13-year follow-up (dietary and medical status), constitute the reference population to determine the mechanisms involved in the insulin resistance development in aging.

The purpose of our research work is to determine whether the quality of aging could influence insulin sensitivity, by studying metabolic profile and change in gene expression (genes involved in glucose metabolism and metabolic senescence in muscle tissue) during aging.


Condition Intervention
Insulin Sensitivity
Aging
Drug: euglycemic hyperinsulinemic clamp
Procedure: muscle biopsy
Device: indirect calorimetry

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Implication of Metabolic and Genomic Modifications in Elderly Subjects

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Comparison of metabolic profile (lipid metabolism and energy expenditure) and insulin sensitivity based on the aging quality [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gene expression in muscle tissue by quantitative RT-PCR: genes involved in the carbohydrates and lipids metabolism (lipid carriers, PPARs), 7 sirtuins isoforms and of their target genes (NFkB, PGC1a) [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Gene expression in muscle tissue by Global transcriptome analysis by DNA Chip [ Time Frame: one day ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: May 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Problematic aging Drug: euglycemic hyperinsulinemic clamp

Insulin perfusion at 1 mU.kg-1.min-1

Glucose perfusion to maintain euglycemia at 5,0 ± 0,5 mmol/l

Blood tests

Procedure: muscle biopsy

Gene expression in muscle tissue will be studied with two approaches :

  • Candidate gene approach by quantitative RT-PCR : genes involved in the carbohydrates and lipids metabolism including lipid oxidation in muscle (lipid carriers, PPARs), expression of 7 sirtuins isoforms as well as some of their target genes (NFkB, PGC1a)
  • Global transcriptome analysis by DNA Chip
Device: indirect calorimetry
energy expenditure measurement
Experimental: successful aging Drug: euglycemic hyperinsulinemic clamp

Insulin perfusion at 1 mU.kg-1.min-1

Glucose perfusion to maintain euglycemia at 5,0 ± 0,5 mmol/l

Blood tests

Procedure: muscle biopsy

Gene expression in muscle tissue will be studied with two approaches :

  • Candidate gene approach by quantitative RT-PCR : genes involved in the carbohydrates and lipids metabolism including lipid oxidation in muscle (lipid carriers, PPARs), expression of 7 sirtuins isoforms as well as some of their target genes (NFkB, PGC1a)
  • Global transcriptome analysis by DNA Chip
Device: indirect calorimetry
energy expenditure measurement

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Volunteers from the cohort aging SUVIMAX 2
  • Men and Women
  • over 60 years
  • BMI between 18 and 35 kg/m2 (including terminals)
  • Normal medical check up
  • Blood pressure < 140/90 mmHg
  • Normal glycemia, lipid profile
  • sedentary or moderate physical activity (maximum 4 hours per week)

Exclusion Criteria:

  • Biological results or anormal chek-up
  • medical or surgical history not compatible with study
  • severe digestive, cardiovascular, renal, liver or tumor disorders history in the 5 last years
  • infectious or inflammatory disease within 2 months
  • surgical history within 3 months
  • bood donation within 2 months
  • coagulation disease, anticoagulant or antiplatelet agents (aspirin ...) treatment
  • xylocaïn allergy
  • claustrophobia
  • Drug that could affect insulin sensitivity (beta blockers, lipid lowering, oral antidiabetics, insulin, , steroids)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00951392

Locations
France
Centre de recherche en nutrition humaine Rhône-Alpes
Pierre-Bénite, France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Martine LAVILLE, MD, PhD Centre de recherche en nutrition humaine Rhône-Alpes
  More Information

No publications provided

Responsible Party: Martine Laville PhD, MD, Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00951392     History of Changes
Other Study ID Numbers: 2008.547
Study First Received: July 31, 2009
Last Updated: March 8, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Insulin sensitivity
aging
lipid metabolism
hyperinsulinemic clamp
gene expression
sirtuins

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases

ClinicalTrials.gov processed this record on October 21, 2014